Paragraph 39 Variation of marketing authorisations

Subject to sub-paragraph (3) F1and paragraph 39A , if an application to vary a marketing authorisation of a kind described in sub-paragraph (2) is—

the fee payable for that application is the fee payable under regulation 19(1) together with the difference between that fee and the fee which would have been payable if the application had been a major application.

In this paragraph a marketing authorisation is one which has been granted in accordance with an application to which point 6 of Part II of Annex I to the 2001 Directive applies or which is F2an orphan marketing authorisation.

Sub-paragraph (1) and (2) shall not apply where the first application for variation of the marketing authorisation relates to a therapeutic area, in respect of which the applicant would be entitled (had the applicant not already held a marketing authorisation) to apply for a marketing authorisation to which point 6 of Part II of Annex I to the 2001 Directive applies or which is in respect of F3a medicinal product which meets the orphan criteria listed in regulation 50G(2) of the Human Medicines Regulations.